RI.KNEE Tibia Adjustment 4240-7500Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09421028118187), received between Feb 12, 2025 and Feb 12, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Separation Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2025Separation Problem; Separation Problem

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED TKA SURGERY, ONE (1) STRIDE EM TIB ALIGNMENT GUIDE BASE/ARM WAS PLACED IN THE DESIRED LOCATION ON THE TIBIA. A NEW 65 MM HEADLESS PIN WAS DRILLED INTO HOLE. THEN THE PIN APPEARED TO GET STUCK AND WAS NOT SEATED ALL THE WAY DOWN. IT WAS TRIED TO PULL THE PIN OUT, BUT INITIALLY IT WAS NOT POSSIBLE. IT WAS NEEDED TO INCREASE THE FORCE AND A DIFFERENT WIRE DRIVER. ULTIMATELY, IT WAS POSSIBLE TO REMOVE THE MEDIAL PIN FIRST, AND THEN, THE LATERAL PIN FROM THE BONE. HOWEVER, THE LATERAL PIN WAS NOT ABLE TO SEPARATE FROM THE FIXATION BASE ONCE OFF THE BONE. A MALLET WAS USED TO TRY TO SEPARATE THE PIECES. WHEN IT WAS CLEAR THAT THE PIN WAS STUCK, THE PROCEDURE WAS SWITCHED TO MANUAL. THE PIN APPEARED TO BE BENT INTO THE DEVICE. THE PROCEDURE WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY CHANGING TO A MANUAL SURGICAL TECHNIQUE. NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21365395 ↗